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The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals

The TELENEO Trial: A Multicenter Trial of Telemedicine for Advanced Neonatal Resuscitations in Community Hospitals

Recruiting
All
Phase N/A

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Overview

The purpose of this study is to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed teleneonatology) on the early health outcomes of at-risk neonates delivered in community hospitals.

Description

This prospective, multicenter trial will use a stepped wedge cluster randomized study design to evaluate the impact of real-time audio-video telemedicine consults with a neonatologist (termed "teleneonatology") on the risk of early mortality, early morbidity, and delivery room care for at-risk neonates delivered in community hospitals.

Eligibility

Inclusion Criteria:

GROUP 1: Community hospital physicians

        To be eligible to participate in this study, an individual must meet all of the following
        criteria:
          1. A physician who attends newborn resuscitations at a participating community hospital
             spoke site.
          2. Provision of informed oral consent prior to any mandatory study specific procedures
             and analyses.
        GROUP 2: At-risk outborn neonates
        To be eligible for this study, a neonate born in a participating community hospital spoke
        site must meet at least one of the following inclusion criteria
          1. Preterm birth at less than 32 weeks' gestation at delivery; OR
          2. Need for advanced resuscitation defined as:
               1. positive pressure ventilation (PPV) initiated soon after birth and continued for
                  at least 10 minutes; OR
               2. placement of an alternative airway (endotracheal tube or laryngeal mask) to
                  provide PPV; OR
               3. chest compressions.
        Exclusion Criteria:
        GROUP 1: Community hospital physicians
        A physician who meets the following criteria will be excluded from the study:
        1. Completion of a neonatal-perinatal medicine fellowship
        GROUP 2: At-risk outborn neonates
        A neonate born in a participating community hospital spoke site who meets any of the
        following criteria will be excluded from the study:
          1. Birth outside of the hospital birthing center.
          2. Neonatal transport team present at time of birth and providing resuscitative care.
          3. Severe congenital anomaly necessitating intensive care or surgery in the first two
             weeks of life.
          4. Plan for comfort care (non-resuscitation) following delivery.
          5. In-person neonatology-trained physician present for the resuscitation.

Study details
    Death; Neonatal
    Morbidity;Newborn

NCT06087224

Mayo Clinic

18 April 2024

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FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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